Key Principles (Findings)
The central principle illustrated is that the regulatory pathway for data from a Digital Health Technology (DHT) depends on its role in the clinical trial. The flowchart shows that not all data collected via DHTs requires pre-market submission to the FDA. A critical decision point is whether the DHT itself meets the definition of a medical device and whether the data it generates will be used to support a labeling claim. The framework clarifies that the context of use is the primary determinant for the required regulatory interactions.

Recommended Actions (Recommendations)
The flowchart recommends a sequential decision-making process for sponsors. First, determine if the DHT is a medical device. Based on that outcome, the sponsor is guided to assess if the data will be used to evaluate a primary or secondary endpoint. The ultimate recommendation of the flowchart is that sponsors should formally engage with the FDA through mechanisms like the pre-submission (Q-Submission) process to gain clarity and feedback on their specific use case, particularly when the DHT data is intended to support a primary or secondary endpoint.

Regulatory Considerations
The flowchart visualizes key regulatory considerations for sponsors. It highlights that if a DHT is considered a medical device and is being used to support a pivotal trial, an Investigational Device Exemption (IDE) may be required. The data generated from the DHT is typically submitted to the FDA as part of an Investigational New Drug (IND) application, a New Drug Application (NDA), or a Biologics License Application (BLA). The resource makes it clear that even if a DHT itself does not require FDA clearance or approval, the data it generates is subject to FDA review when submitted in support of a medical product.